Myocardial InfarctionPhase 4NCT01372930
Etanercept Treating Patient With Acute ST Segment Elevated Myocardial Infarction
A Phase 4 study testing Etanercept and saline in people with Myocardial Infarction, run by Xijing Hospital at 1 site in China.
Trial summary
Our aim is to observe whether anti-TNF-alpha regimen will effect serum adiponectin concentration after myocardial infarction/reperfusion and also beneficial for the patients undergoing percutaneous coronary intervention (PCI). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Etanercept and saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Apr 2010to Jul 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with acute ST segment elevated myocardial infarction in 12h
Who cannot join
- Cardiogenic shock
- old myocardial infarction
- other causes of cardiac insufficiency
- tumor
- Coronary anatomy unsuitable for PCI or Need of emergency coronary artery by-pass grafting
- Pregnancy
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xijing Hospital
Xi'an, Shaanxi, 710032
Ling Tao, M.D Ph.D, +86-15002955798, lingtao2006@gmail.com
Ling Tao, M.D Ph.D
About this study
Official title: The Safety and Efficacy of Etanercept in Treating Patient With Acute ST Segment Elevated Myocardial Infarction
Our aim is to observe whether anti-TNF-alpha regimen will effect serum adiponectin concentration after myocardial infarction/reperfusion and also beneficial for the patients undergoing percutaneous coronary intervention (PCI).
Read the detailed description
Ischemic/reperfusion injury in patients with acute myocardial infarction (AMI) undergoing percutaneous coronary intervention (PCI) is associated with increased inflammatory cytokines that including TNF-alpha that can exert deleterious effects and therefore contribute to cardiac dysfunction and cardiomyocytes apoptosis. Several studies on rodents have reported administration of sTNFR-Fc, a scavenger of the pro-inflammatory cytokine TNF-alpha at the time of reperfusion would protect against ischemic/reperfusion injury. Also reports had shown that serum TNF-alpha concentration is negatively correlated with a cardioprotective cytokine adiponectin. Adiponectin (Ad) is an abundant protein hormone regulatory of numerous metabolic processes. The major intracellular pathway activated by Ad includes phosphorylation of AMP-activated protein kinase, which is responsible for many of Ad's metabolic regulatory, anti-inflammatory, vascular protective, and anti-ischemic properties. The aim of the present study was to verify whether the administration of Etanercept, an FDA approved rheumatoid arthritis treating sTNFR-Fc, at the reperfusion time would protect against ischemic/reperfusion injury on patient, and effect serum adiponectin level.
- Conditions
- Myocardial Infarction
- Being tested
- Etanercept, saline
- Keywords
- Etanercept, acute ST segment elevated myocardial infarction, percutaneous coronary intervention, myocardial reperfusion injury
- Medical subject headings
- Myocardial Infarction, Myocardial Reperfusion Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtanerceptDrug
Also called Enbrel
Etanercept 25mg in 1ml(subcutaneous injection)at 2h and 72h after PCI
salineDrug
saline 1ml(subcutaneous injection) at 2h and 72h after PCI
| Study group | Role | What they receive |
|---|---|---|
| Etanercept | Experimental | Not described Receives: Drug: Etanercept |
| saline | Placebo comparator | Not described Receives: Drug: saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of major adverse cardiovascular events (MACE) consisting of cardiovascular death, fatal myocardial infarction and fatal stroke
Measured: 30 days
Secondary outcomes (3)
Composite endpoint of major cardiovascular events, non-elective coronary revascularization procedures and hospitalization for unstable angina Cardiovascular death Non-fatal myocardial infarction Non-fatal stroke of all classifications
Measured: 30 days
Elevation of ALT, AST and CK
Measured: 30 days
serum adiponectin concentration, activity and isoforms
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2011 (estimated)
- Study startApr 2010
- Primary completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01372930
- Sponsor's protocol ID
- xjyy110504
- Status last verified
- Mar 2010
- First submitted
- 10 Jun 2011
- Last updated
- 14 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of Etanercept in Treating Patient With Acute ST Segment Elevated Myocardial Infarction
- ClinicalTrials.gov ID
- NCT01372930
- Acronym / sponsor ID
- xjyy110504
- Conditions
- Myocardial Infarction
- Keywords
- Etanercept, acute ST segment elevated myocardial infarction, percutaneous coronary intervention, myocardial reperfusion injury
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Jul 2014 (estimated)
- First posted
- 14 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Our aim is to observe whether anti-TNF-alpha regimen will effect serum adiponectin concentration after myocardial infarction/reperfusion and also beneficial for the patients undergoing percutaneous coronary intervention (PCI).
Detailed description
Ischemic/reperfusion injury in patients with acute myocardial infarction (AMI) undergoing percutaneous coronary intervention (PCI) is associated with increased inflammatory cytokines that including TNF-alpha that can exert deleterious effects and therefore contribute to cardiac dysfunction and cardiomyocytes apoptosis. Several studies on rodents have reported administration of sTNFR-Fc, a scavenger of the pro-inflammatory cytokine TNF-alpha at the time of reperfusion would protect against ischemic/reperfusion injury. Also reports had shown that serum TNF-alpha concentration is negatively correlated with a cardioprotective cytokine adiponectin. Adiponectin (Ad) is an abundant protein hormone regulatory of numerous metabolic processes. The major intracellular pathway activated by Ad includes phosphorylation of AMP-activated protein kinase, which is responsible for many of Ad's metabolic regulatory, anti-inflammatory, vascular protective, and anti-ischemic properties. The aim of the present study was to verify whether the administration of Etanercept, an FDA approved rheumatoid arthritis treating sTNFR-Fc, at the reperfusion time would protect against ischemic/reperfusion injury on patient, and effect serum adiponectin level.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Etanercept | Experimental | Drug: Etanercept |
| saline | Placebo comparator | Drug: saline |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with acute ST segment elevated myocardial infarction in 12h
Key exclusion criteria (6 listed)
- Cardiogenic shock
- old myocardial infarction
- other causes of cardiac insufficiency
- tumor
- Coronary anatomy unsuitable for PCI or Need of emergency coronary artery by-pass grafting
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EtanerceptAlso: EnbrelEtanercept 25mg in 1ml(subcutaneous injection)at 2h and 72h after PCI | Drug | Etanercept |
| salinesaline 1ml(subcutaneous injection) at 2h and 72h after PCI | Drug | saline |
Primary outcome
Composite of major adverse cardiovascular events (MACE) consisting of cardiovascular death, fatal myocardial infarction and fatal stroke
Time frame: 30 days
3 secondary outcomes
Composite endpoint of major cardiovascular events, non-elective coronary revascularization procedures and hospitalization for unstable angina Cardiovascular death Non-fatal myocardial infarction Non-fatal stroke of all classifications
Time frame: 30 days
Elevation of ALT, AST and CK
Time frame: 30 days
serum adiponectin concentration, activity and isoforms
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2011.
Related trials for Myocardial Infarction
Not yet recruitingObservational study
Elicit Drugs in Myocardial Infarction
Young Patients With Acute Myocardial Infarction
Enrolling by invitation
The DANE-HEART Trial - Computed Tomography Coronary Angiography for Primary Prevention
Coronary Atherosclerosis and Other Heart Disease, Cardiovascular Diseases
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Etanercept and saline in people with Myocardial Infarction, run by Xijing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ling Tao, M.D Ph.D (+86-15002955798, lingtao2006@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of major adverse cardiovascular events (MACE) consisting of cardiovascular death, fatal myocardial infarction and fatal stroke (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2011.